Quality Engineer

Stark Pharma Solutions Inc

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Quality Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Role: Quality Engineer

Location: West Valley City, UT (100% Onsite)

Duration: 12+ Months

Position Overview

We are seeking an experienced

Quality Engineer to support design quality, integration, and remediation initiatives within a regulated medical device environment. This role requires strong technical expertise in Design Controls, Risk Management, Verification & Validation (V&V), and Technical Risk Management (TRM/TMV), with the ability to independently develop, execute, and support quality engineering activities throughout the product lifecycle.

Key Responsibilities

Support New Product Development (NPD) and Design Quality activities in compliance with FDA 21 CFR Part 820 and applicable quality standards.
Lead and support Design History File (DHF) remediation and design integration projects.
Develop and execute risk management activities, including risk assessments, hazard analyses, and mitigation strategies.
Author and review design control documentation, V&V protocols, reports, and technical files.
Support implementation of Design for Manufacturability (DFM) principles and quality improvements.
Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality.
Participate in major remediation and integration initiatives to ensure compliance and product quality.
Support design transfer, change management, and lifecycle management activities.

Required Qualifications

Bachelor s degree in Engineering or a related technical discipline.
4+ years of Quality Engineering experience within the medical device industry.
Strong experience with Design Controls and FDA 21 CFR Part 820 requirements.
Hands-on experience developing and executing Risk Management and Verification & Validation (V&V) activities.
Experience supporting design integration, DHF remediation, and quality system improvement initiatives.
Strong technical writing, problem-solving, and cross-functional collaboration skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: ***email_hidden***

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854